A Multi-center, Open-label Study of Oral ENMD-2076 for the Treatment of Patients With Advanced Fibrolamellar Carcinoma

Inclusion Criteria

• •Histologically or cytologically confirmed advanced fibrolamellar carcinoma (FLC).
• •All forms of prior local therapy are allowed as long as patients have either a target lesion, which has not been treated with local therapy and/or the target lesion(s) within the field of the local-regional therapy has shown an increase of ≥ 20% in size. Local-regional therapy must be completed at least 4 weeks prior to the baseline CT scan. Local therapies including chemoembolization do not count as prior systemic therapy.
• •Are at least 4 weeks from major surgery and recovered.
• •At least one measureable lesion by RECIST 1.1.
• •Male or non-pregnant, non-breastfeeding female at least 18 years of age. Patients aged at 12\~18 years may be recruited but only at the site principle investigator's request and subject to Institutional Review Board (IRB) approval.
• •Has a pre-study echocardiogram or multi-gated acquisition (MUGA) scan with an actual left ventricular ejection fraction of greater than or equal to the institutional lower limit of normal within one month of initiating therapy.
• •Have clinically acceptable laboratory screening results within certain limits specified below:
• •* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 times upper limit of normal (ULN)
• •* Total bilirubin ≤ 3.0 x ULN
• •* Creatinine ≤ 1.5 x ULN or Cr Cl \> 60 cc/min
• •* Absolute neutrophil count ≥ 1500 cells/mm3
• •* Platelets ≥ 50,000/mm3
• •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 for ≥ 16 years of age and a Lansky performance status of 70-100 for \< 16 years of age
• •Women and men of child producing potential must agree to use effective contraceptive methods prior to study entry, during study participation, and for at least 30 days after the last administration of study medication. A serum pregnancy test within 72 hours prior to the initiation of therapy will be required for women of childbearing potential.
• •Have the ability to understand the requirements of the study, provide written informed consent, which includes authorization for release of protected health information, abide by the study restrictions, and agree to return for the required assessments.